NCT01755819

Brief Summary

Background: Failure of graft incorporation and tunnel widening (TW) after anterior cruciate ligament (ACL) reconstruction has been frequently reported in the literature. The etiology of TW is still not fully understood. Patients and Methods: This is a prospective randomized study including 60 patients, conducted in a Level I trauma center in Innsbruck, Austria. The study protocol was approved by the hospital ethics committee. This study is planned and conducted following the Consolidated Standards on Reporting Trials (CONSORT) guidelines. Aperture fixation is performed using BioComposite interference screws (Arthrex, Naples, FL). Extracortical fixation is performed using the ACL Tightrope (Arthrex, Naples, FL). TW is measured on CT scan postoperative, after 6 and 24 months. Clinical outcome is determined at 1, 2 after reconstruction, IKDC with KOOS Knee-related QoL subscale, Lysholm, Tegner Activity scores, hop tests and KT-1000 measurements are performed. Hypothesis: The purpose of this randomized controlled trail is to determine the influence of two different fixation methods on TW and clinical outcome after anatomic ACL reconstruction using hamstring graft in young and active patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3 years

First QC Date

December 4, 2012

Last Update Submit

January 15, 2013

Conditions

ACL Anterior Cruciate Ligament InjuryOutcome

Outcome Measures

Primary Outcomes (1)

  • Change of tunnel volume and diameter from baseline up to 2 year follow up

    CT tunnel measurements are conducted. Tunnel volume are calculated by CT volumetry measured in mm³ and tunnel diameter is measured in mm.

    1-2 days before (knee) operation, 6 months FU, 2 year FU

Secondary Outcomes (6)

  • Clinical outcome: international knee score evaluating objective and subjective knee outcome variables

    1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU

  • Clinical outcome: influence on quality of life after knee ACL reconstruction

    1-2 days before (knee)operation, 6 month FU, 1 year FU, 2year FU

  • Clinical outcome: subjective evaluation of knee function

    1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU

  • Clinical outcome: return to sports activity

    1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU

  • Clinical outcome: strength in single leg jumping after ACL reconstruction

    1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU

  • +1 more secondary outcomes

Study Arms (2)

Biocomposite interference screw

OTHER

Thirty patients treated with ACL reconstruction and graft fixation is performed using Biocomposite interference screw on tibial and femoral side. Patients are randomized to one of the two study arms.

Device: Biocomposite interference screw

Extracortical ACL Tightrope fixation

OTHER

Thirty patients treated with ACL reconstruction and graft fixation is performed using extracortical ACL Tightrope fixation on tibial and femoral side. Patients are randomized to one of the two study arms.

Device: Extracortical ACL Tightrope fixation

Interventions

Biocomposite interference screwDEVICE
Biocomposite interference screw
Extracortical ACL Tightrope fixationDEVICE
Extracortical ACL Tightrope fixation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The ACL injury can be either "isolated" or combined with one or several of the following injuries visualized on MRI and/or arthroscopy:
  • A meniscus tear that is either left untreated or treated with a partial resection
  • A small, stable meniscus tear treated with fixation, but fixation not interfering with the rehabilitation protocol
  • Cartilage changes verified on MRI with arthroscopically determine intact surface
  • A radiographic examination with normal joint status or combined with either one of the following finding:
  • A small avulsed fragment located laterally, usually described as a Second fracture
  • JSN grade 1 or osteophytes grade 1 as determined by the OARSI atlas (Altman et al. 1995)

You may not qualify if:

  • Presence of one of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy:
  • An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol
  • Bi-compartmental extensive meniscus resection
  • A cartilage injury representing a full thickness loss down to bone
  • A total rupture of MCL/LCL as visualized on MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck (Traumasurgery)

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (2)

  • Eichinger M, Ploner M, Degenhart G, Rudisch A, Smekal V, Attal R, Mayr R. Tunnel widening after ACL reconstruction with different fixation techniques: aperture fixation with biodegradable interference screws versus all-inside technique with suspensory cortical buttons. 5-year data from a prospective randomized trial. Arch Orthop Trauma Surg. 2023 Nov;143(11):6707-6718. doi: 10.1007/s00402-023-05001-x. Epub 2023 Aug 5.

    PMID: 37542556DERIVED

  • Mayr R, Smekal V, Koidl C, Coppola C, Eichinger M, Rudisch A, Kranewitter C, Attal R. ACL reconstruction with adjustable-length loop cortical button fixation results in less tibial tunnel widening compared with interference screw fixation. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1036-1044. doi: 10.1007/s00167-019-05642-9. Epub 2019 Aug 1.

    PMID: 31372680DERIVED

Study Officials

  • Rene El Attal, Dr.

    Medical University Innsbruck (Traumasurgery)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rene EL Attal, Dr.

CONTACT

0043-50-504-80875rene.attal@uki.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 24, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

AU(1)